TECNIS IOL PCB00 (REF PCB0000195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 05050474558250), received between Aug 24, 2016 and Jun 4, 2024 — classified as 27 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Break” (33 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BROKEN DURING IMPLANTATION AS THE ROD PASSED OVER THE LENS DAMAGING IT. THROUGH FOLLOW-UP WE LEARNED THAT NO PART OF THE IOL CAME IN CONTACT WITH THE PATIENT. THE MATERIAL HAS BEEN DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463945 ↗
• MalfunctionJun 4, 2024Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BROKEN DURING IMPLANTATION AS THE ROD PASSED OVER THE LENS DAMAGING IT. THROUGH FOLLOW-UP WE LEARNED THAT NO PART OF THE IOL CAME IN CONTACT WITH THE PATIENT. THE MATERIAL HAS BEEN DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462590 ↗
• MalfunctionApr 12, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT WHILE IMPLANTING THE PRELOADED INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE THE CARTRIDGE TIP WAS DAMAGED CAUSING THE LENS TO BE DAMAGED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728801 ↗
• MalfunctionJan 13, 2023Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THE PRE-LOADED PCB00 PLUNGER DID NOT EJECT PCB00 INTRAOCULAR LENS (IOL) CORRECTLY AND THE LENS WAS DAMAGED. IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE IOL WAS PARTIALLY INSERTED. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DCB00 19.5 IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164811 ↗
• MalfunctionNov 8, 2022Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT WHILE ADVANCING THE INTRAOCULAR LENS (IOL), THE HAPTIC WAS ALREADY OUTSIDE. "HALF IOL" WAS MENTIONED WHICH IS TAKEN TO MEAN THAT THE IOL WAS DAMAGED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756951 ↗
• MalfunctionApr 22, 2022Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS PUSHED WRONGLY BY THE INJECTOR PRIOR TO PATIENT INVOLVEMENT. FURTHER FOLLOW UP REVEALED THAT THERE WAS A PROBLEM WITH THE PISTON AND THE LENS CAME OUT BADLY CRUMPLED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190480 ↗
• MalfunctionMar 31, 2022Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE LENS. NO PATIENT INVOLVEMENT REPORTED AND NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966892 ↗
• MalfunctionDec 27, 2021Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Failure to Advance; Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Failure to Advance

  IT WAS REPORTED THAT AFTER IMPLANTATION ACCORDING TO THE DFU (DIRECTIONS FOR USE), THE LAST PUSH WAS GIVEN AND THE TRAILING HAPTIC UNFOLDED AND STAYED IN THE CARTRIDGE. THE HAPTIC WAS NOT FOLDED ON THE OPTIC OF THE LENS AND THE DOCTORS GOT IT OUT OF THE CARTRIDGE WITHOUT DAMAGE, REQUIRING A SECONDARY TOOL TO FREE THE LENS. THERE WAS A DELAY IN PROCEDURE; HOWEVER, NO PATIENT ISSUES REPORTED AND NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13091109 ↗
• MalfunctionNov 18, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12841086 ↗
• MalfunctionOct 27, 2021Crack; Mechanical Jam; Crack; Mechanical Jam

  CUSTOMER REPORTED THAT THEIR SYSTEM OF INJECTION OF THE INTRAOCULAR LENS (IOL) PCB00 WAS BROKEN. THAT THEY COULD NOT GO FORWARD WITH THE IOL BY PUSHING THE PISTON AND INDICATED THE TIP OF THE CARTRIDGE IS DEFECTIVE. CUSTOMER DETECTED THE ISSUE WHEN THE PHYSICIAN HAD ALREADY STARTED THE IMPLANT OF THE IOL IN THE PATIENT, THE CARTRIDGE WAS INTRODUCED IN THE EYE OF THE PATIENT. THE CUSTOMER HAD TO DISCARD THE IOL, OCCURRING A DELAY OF 30 MINUTES IN THE SURGERY, AND WITH THE CATARACT REMOVED. THERE WAS NO SURGICAL INTERVENTIONS REPORTED. IT WAS INDICATED THAT ANOTHER LENS WAS USED. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12706055 ↗
• MalfunctionOct 22, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DAMAGED. THROUGH FOLLOW-UP IT WAS CLARIFIED THAT AFTER THE LENS WAS INSERTED IN THE EYE IT WAS NOTED THAT ONE HAPTIC WAS MISSING. THE LENS WAS REMOVED FROM THE EYE AND REPLACED WITH ANOTHER LENS OF THE SAME DIOPTER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685769 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, WAS REMOVED AS THE DOCTOR NOTICED A HOLE IN THE CAPSULAR BAG. IT WAS ALSO STATED THAT THE HOLE WAS NOT CAUSED BY THE LENS, BUT IT WAS UNNOTICED PRIOR TO THE PLACEMENT OF THE LENS. VITRECTOMY WAS PERFORMED AND ANOTHER LENS OF DIFFERENT MODEL AND DIOPTER (ZA9003, 19.5 D) WAS PLACED AS THE REPLACEMENT. THERE WAS NO OTHER INJURY TO THE PATIENT AND THE PATIENT WAS DOING FINE POST-OPERATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12596035 ↗
• MalfunctionJul 29, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PCB LENS WAS PREPARED ACCORDING TO INSTRUCTIONS, NO PROBLEMS WITH THE FIRST ADVANCE, THEN IT WAS NOTICED THAT THE IOL (INTRAOCULAR LENS) IS NOT COMPLETELY STRAIGHT IN THE CARTRIDGE, BUT IT WAS NOT DIFFICULT TO PUSH / TURN, IOL WAS IMPLANTED IN THE PATIENT'S RIGHT EYE. UNDER THE MICROSCOPE, DAMAGE (SCRATCHES OR CRACKS) WAS FOUND CENTRALLY TO THE IOL OPTICS, APPROX. 1MM. THE PATIENT WILL BE EXAMINED IN A WEEK, THE DOCTOR WILL CONTACT THE TERRITORY MANAGER AGAIN IF THE PATIENT DETECTS A DISTURBANCE AND THE IOL MAY HAVE TO BE REPLACED. CONDITION IS AFTER MYOPIC LASIK. PRE OPERATIVE VISION WAS 0.8. POST OPERATIVE VISION IS NOT YET KNOWN. NO INTERVENTIONS WERE MENTIONED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247471 ↗
• MalfunctionJul 21, 2021Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP CRACKED WHEN THE LENS SHOULD BE INJECTED. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION/APPLICATION. THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. THE CUSTOMER HAS NO FURTHER INFORMATION THAN WHAT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207985 ↗
• MalfunctionJul 15, 2021Crack; Material Too Rigid or Stiff; Crack; Material Too Rigid or Stiff

  IT WAS REPORTED THAT WHEN THE NURSE PUSHED THE PLUNGER FORWARD THEY NOTICED THE PRELOADED LENS WAS HARDER AND SLOWER TO PUSH FORWARD COMPARED TO OTHER PRELOADED LENSES THAT DID NOT PRESENT WITH ANY ISSUE AS ALL WENT WELL. THE SURGEON LATER TRIED TO IMPLANT THE LENS AND NOTICED THAT THE TIP OF THE PLUNGER ALMOST PUSHED THRU THE CARTRIDGE. THE DOCTOR STOPPED THE IMPLANTATION AND OPENED A NEW LENS WHICH WAS SUCCESSFULLY IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176089 ↗
• MalfunctionJul 15, 2021Break; Inaccurate Delivery; Scratched Material; Break; Inaccurate Delivery; Scratched Material

  IT WAS REPORTED WHEN INSERTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) THE LENS WAS SCRATCHED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THERE WAS NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS WITH THE SAME MODEL AND DIOPTER SIZE. THE PATIENT OUTCOME WAS REPORTED AS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171531 ↗
• MalfunctionJul 14, 2021Break; Scratched Material; Break; Scratched Material

  CUSTOMER REPORTED A DEFECTIVE PCB00 INTRAOCULAR LENS (IOL) DUE TO IT BEING SCRATCHED. AFTER THE IOL WAS FULLY INSERTED, DURING THE LAST CHECK-UP AND CLEANING OF THE EYE, IT WAS NOTICED THE LENS WAS SCRATCHED. THE IOL WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH A NEW LENS. THE PATIENT FULLY RECOVERED AND THEIR DAILY ACTIVITIES WERE NOT AFFECTED. THERE WAS NO INCISION ENLARGEMENT. NO VITRECTOMY REQUIRED, AND NO MEDICATION PRESCRIBED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170827 ↗
• MalfunctionJul 14, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT''S RIGHT EYE AND WAS REMOVED DURING THE SAME PROCEDURE DUE TO A SCRATCH THAT LOOKED LIKE THE IOL WAS CRACKED. THERE WAS NO PATIENT INJURY, AND NO MEDICAL/SURGICAL INTERVENTION SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES WERE REQUIRED. THE LENS WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THE PATIENT IS DOING OKAY POST-OP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170769 ↗
• MalfunctionMay 4, 2021Break; Break

  THE SURGERY CENTER REPORTED BROKEN LENS WITH AN INTRAOCULAR LENS (IOL). THE ACCOUNT DID NOT KNOW IF THERE WAS ANY PATIENT CONTACT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT'S ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770482 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THREE PIECE LENS WAS NEEDED DUE TO CAPSULE RUPTURE AND THE IMPLANTED ONE PIECE LENS (PCB00) WAS REMOVED AND REPLACED WITH ZA9003 MODEL INTRAOCULAR LENS. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 11682796 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL) WAS FULLY INSERTED, THEN REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO LENS FALLING TO BACK OF THE EYE, UNABLE TO PLACE. THE LENS AND CARTRIDGE CONTACTED PATIENT'S EYE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO MEDICAL INTERVENTION, NO SUTURES, NO INJURY AND NO INCISION ENLARGEMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11548590 ↗
• MalfunctionMar 17, 2021Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT A PARTIALLY INSERTED INTRAOCULAR LENS INTO A PATIENT'S RIGHT EYE WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO BENT/BROKEN HAPTIC. THERE WAS A PATIENT CONTACT WITH THE LENS. THE PROCEDURE WAS COMPLETED WITH THE SAME MODEL AND DIOPTER LENS. IT WAS INDICATED THAT THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506543 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT A PRELOADED PRODUCT HAD LENS DAMAGED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402345 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S LEFT EYE AND REMOVED AND REPLACED WITH A Z9002 MODEL LENS SN: (B)(4) IN THE SULCUS AS THE PATIENT RECEIVED A VITRECTOMY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT HAD ZONULAR DEHISCENCE. A 10-0 NYLON SUTURE WAS ALSO PLACED AS THE WOUND WOULD NOT SEAL WITH BSS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Zonular Dehiscence

  MAUDE report 11376174 ↗
• InjuryNov 11, 2020Break; Break

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING TWO (02) UNPLANNED SUTURE(S). THERE WAS NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, AND NO UNPLANNED VITRECTOMY. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS WITH SAME MODEL AND DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10826427 ↗